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Published byJason Whitehead Modified over 6 years ago
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Acknowledgements Thai Cochrane Network Prof. Malinee Laopaiboon
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Steps of conducting a Cochrane review
1. Define review question 2. Plan eligibility criteria 3. Plan methods 4. Search for studies 5. Selecting studies 6. Collecting data 7. Assess study for risk of bias 8. Analyse and present results 9. Interpret results and form conclusions 10. Improve and update review Register title Publish protocol Publish review Publish update
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Data extraction and management
Selection of studies Data extraction and management
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Identifying multiple reports from the same study
Author names Location and setting Specific details of the interventions Numbers of participants and baseline data Date and duration of the study Registration no. 7.2.2 Identifying multiple reports from the same study Duplicate publication can introduce substantial biases if studies are inadvertently included more than once in a meta-analysis (Tramèr 1997). Duplicate publication can take various forms, ranging from identical manuscripts to reports describing different numbers of participants and different outcomes (von Elm 2004). It can be difficult to detect duplicate publication, and some ‘detective work’ by the review authors may be required. Some of the most useful criteria for comparing reports are: Author names (most duplicate reports have authors in common, although it is not always the case); Location and setting (particularly if institutions, such as hospitals, are named); Specific details of the interventions (e.g. dose, frequency); Numbers of participants and baseline data; Date and duration of the study (which can also clarify whether different sample sizes are due to different periods of recruitment). Where uncertainties remain after considering these and other factors, it may be necessary to correspond with the authors of the reports.
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Minimising bias in selection
selecting studies involves judgement, and is highly influential on the outcomes of the review compare each record with pre-specified eligibility criteria - written summary or checklist may be helpful two authors should independently select studies - discussion may identify issues for clarification or gaps in your eligibility criteria - pilot selection on a few papers first - disagreements can usually be resolved by discussion or referral to a third author
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What to include in your protocol
whether two authors will independently assess studies process of assessment (e.g. abstracts, full text) how disagreements will be managed any other methods used
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Kietpeerakool C, Supoken A, Laopaiboon M, Lumbiganon P
Effectiveness of tranexamic acid in reducing blood loss during cytoreductive surgery for advanced ovarian cancer (Protocol) Kietpeerakool C, Supoken A, Laopaiboon M, Lumbiganon P
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What about studies with no usable data?
Studies must be included in the review if they meet your criteria - results reported in non- standard ways should still be reported in the review - studies that do not report outcomes of interest may have measured them – beware of selective reporting - studies that did not measure outcomes of interest may only be excluded if outcomes were pre- specified as part of your eligibility criteria
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Process for selecting studies
Merge search results Examine titles and abstracts Examine full text reports Correspond with investigators Make final decisions 7.2.3 A typical process for selecting studies A typical process for selecting studies for inclusion in a review is as follows (the process should be detailed in the protocol for the review). Merge search results using reference management software, and remove duplicate records of the same report (see Chapter 6, Section 6.5); Examine titles and abstracts to remove obviously irrelevant reports (authors should generally be over-inclusive at this stage); Retrieve full text of the potentially relevant reports; Link together multiple reports of the same study (see Section 7.2.2); Examine full text reports for compliance of studies with eligibility criteria; Correspond with investigators, where appropriate, to clarify study eligibility (it may be appropriate to request further information, such as missing results, at the same time); Make final decisions on study inclusion and proceed to data collection.
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Selecting studies (I) Merge search results from resource MEDLINE
EMBASE……….. Search results merge
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Selecting studies (II)
Remove duplicate records Search results
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Selecting studies (III)
Examine title and abstracts Exclude obviously irrelevant reports Title………… Abstract…… Title…… Abstract…… Potentially relevant reports Title………… Abstract…… Title………… Abstract…… Title………… Abstract…… should be done independently by at least two review authors
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Selecting studies (IV)
Retrieve and examine full text reports Search results Title………… Abstract…… Title………… Abstract…… Retrieve full text and examine Title………… Abstract…… should be done independently by at least two review authors
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Selecting studies (V) Compare selected studies done by two independent reviewers Search results Title…………… Abstract…… 2nd review author Judgment exclude Search results Title…………… Abstract…… 1st review author Judgment exclude Address reasons for study exclusion How disagreements are handle?
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Selecting studies (VI)
Search results Title…………… Abstract…… 1st+ 2nd review author Judgment exclude Correspond with investigators Make final decisions
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Selecting ‘excluded studies’
By listing such studies as excluded and giving the primary reason for exclusion. The list of excluded studies should be as brief as possible. 7.2.5 Selecting ‘excluded studies’ A Cochrane review includes a list of excluded studies, detailing any studies that a reader might plausibly expect to see among the included studies. This covers all studies that may on the surface appear to meet the eligibility criteria but on further inspection do not, and also those that do not meet all of the criteria but are well known and likely to be thought relevant by some readers. By listing such studies as excluded and giving the primary reason for exclusion, the review authors can show that consideration has been given to these studies. The list of excluded studies should be as brief as possible. It should not list all of the reports that were identified by a comprehensive search. It should not list studies that obviously do not fulfil the entry criteria for the review as listed under ‘Types of studies’, ‘Types of participants’, and ‘Types of interventions’, and in particular should not list studies that are obviously not randomized if the review includes only randomized trials.
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The PRISMA Flow Diagram
The flow diagram depicts the flow of information through the different phases of a systematic review. It maps out the number of records identified, included and excluded, and the reasons for exclusions.
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PRISMA 2009 Flow Diagram
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Data extraction and management
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What data should you collect?
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Key elements of data extraction form (I) (Table 7.3a)
Part 1: Source • Title of Review • Reviewer • Study ID • Citation and contact details
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Key elements of data extraction form (II)
Part 2: Eligibility information This part is used to complete the “Characteristics of included studies table” Components: Methods Participants Interventions Outcomes Help in making decision of study exclusion
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Key elements of data extraction form (III)
Part 3 : Study details Methods Assessment risk of bias Participants Information of each intervention Outcome information Results Other information e.g. source of funding
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Collecting outcome data
Focus on those outcomes specified in your protocol - Be open to unexpected finding e.g. adverse effects Measures used Definition (diagnostic criteria, threshold) Timing Unit of measurement For scales (upper and lower limits, direction of benefit)
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Collecting outcome data (cont.)
Numerical results May be in many formats – conversion may be required Collect whatever is available no. participants for each outcome & time point
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Dichotomous outcomes
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Data in many formats Outcome Reported as Trials
Volume transfused (mls) Mean and SEM Mean and SD Mean and something in brackets Two unlabelled numbers e.g. x(y) Bar chart showing mean per person year 4 2 1 Units transfused Mean only Total in each group Volume adjusted for patient mass (mls/kg) Patient who had a transfusion Number of patients 3 Not reported
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Putting into practice Data collection forms
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Rationale for data collection form
Linked directly to Review question Criteria for assessing eligibility of study
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Data collection forms Organise all the information you need
- reminds what to collect - records what was not reported in the study - records the decision that make about each study Must be tailored to your review - adapt from a good example Paper or electronic
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Minimising bias in data collection
Two authors should independently collect study characteristics and outcome data Reduces error Checks agreement on subjective judgment and interpretations Complementary disciplines (methodologist/ topic area specialist) Resolving disagreements By discussion If not, refer to a third author Pilot data collection process Include each person assisting Check criteria are consistently applied May need to revise form or instructions
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Contacting study authors
To obtain unreported data or confirm unclear data - Missing outcomes, unclear risk of bias Finding contact details Check the study reports Check PubMed for recent publications Check Google for current staff profiles Save all your queries for one request Be clear about what you need Avoid sounding critical Ask for descriptions rather than yes/ no answers
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Managing data Can enter data directly from form to RevMan
May need to consider intermediate steps e.g. Excel spreadsheet Group studies by comparison & outcomes measured Calculations to convert into required statistics Don’t forget to check your final results against those reported in the study
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How disagreement are handled?
Use one author’s (paper) data collection form and record changes after consensus in a different ink color Use a separate (paper) form for consensus data Enter consensus data onto an electronic form
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What include in your protocol
Data categories to be collected Two authors will independently extract data Piloting and use of instructions for data collection form How disagreements will be managed Processes for managing missing data
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Kietpeerakool C, Supoken A, Laopaiboon M, Lumbiganon P
Effectiveness of tranexamic acid in reducing blood loss during cytoreductive surgery for advanced ovarian cancer (Protocol) Kietpeerakool C, Supoken A, Laopaiboon M, Lumbiganon P
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